FDA recall D-0398-2019

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy · Class II · drug

Product

Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments

Reason for recall

Lack of sterility assurance.

Distribution

Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

Key facts

Status
Terminated
Initiation date
2019-01-02
Report date
2019-01-09
Termination date
2023-03-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Roseburg, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0398-2019